Dialysis solution waste minimization systems and methods

ABSTRACT

Dialysis machines and methods for operating dialysis machines (e.g., peritoneal dialysis machines) may include delivering dialysate to a patient and detecting a temperature of a volume of the dialysate, an air content of the dialysate volume, or another condition, or combinations thereof, wherein the detected temperature of the dialysate volume is compared to a predetermined maximum temperature, the detected air content of the dialysate volume is compared to a predetermined maximum air content and the detected other condition generates a signal. The volume of dialysate may be diverted in response to the detected temperature exceeding the predetermined maximum temperature, the air content exceeding the predetermined maximum air content, or the other condition generated signal, or combinations thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of co-pending U.S. patentapplication Ser. No. 15/711,114, filed Sep. 21, 2017, entitled “DialysisSolution Waste Minimization Systems and Methods,” the contents of whichapplication are expressly incorporated by reference herein.

FIELD OF THE DISCLOSURE

The disclosure generally relates to dialysis machines, and moreparticularly to dialysis solution waste minimization systems andmethods.

BACKGROUND OF THE INVENTION

Dialysis machines are known for use in the treatment of renal disease.The two principal dialysis methods are hemodialysis (HD) and peritonealdialysis (PD). During hemodialysis, the patient's blood is passedthrough a dialyzer of a hemodialysis machine while also passingdialysate through the dialyzer. A semi-permeable membrane in thedialyzer separates the blood from the dialysate within the dialyzer andallows diffusion and osmosis exchanges to take place between thedialysate and the blood stream. During peritoneal dialysis, thepatient's peritoneal cavity is periodically infused with dialysate ordialysis solution. The membranous lining of the patient's peritoneumacts as a natural semi-permeable membrane that allows diffusion andosmosis exchanges to take place between the solution and the bloodstream. Automated peritoneal dialysis machines, called PD cyclers, aredesigned to control the entire peritoneal dialysis process so that itcan be performed at home, usually overnight, without clinical staff inattendance.

A dialysis machine, such as a peritoneal dialysis machine, may includebags containing a fluid, e.g., a dialysate for patient infusion. Inperitoneal dialysis machines, for example, tubing as fluid lines areinserted into an abdomen of a patient for flowing fresh dialysate andremoving used dialysate, waste, and excess fluid. In bags containingfresh dialysate, a volume of air (e.g., an air content) may also bepresent, for example, due to fill levels, osmosis, and/or otherconditions. If the dialysis machine draws a combination of dialysate andair content (e.g., air bubbles) from one of the bags or elsewhere in thesystem, the dialysis machine may deliver less than the prescribed volumeof dialysate to the patient over the course of the treatment and/or apotentially painful build-up of excess air in the patient may result.Additionally, dialysate flow may change during treatment, which mayresult in dialysate being overheated and undeliverable at thattemperature to the patient. Other events during treatment may occur aswell, which may affect the delivery of dialysate. In some embodiments, adialysis machine may react to these conditions by alerting the patientvia an alarm or other notification, and may pause or even stop thetreatment. In some embodiments, in order to continue treatment thedialysis machine may automatically purge the dialysate or combination ofdialysate and air content, for example, to a drain. Fresh dialysate thatis drained due to air content volume or temperature, or anothercondition, may waste an unacceptable amount of dialysate, and may resultin the patient not receiving a full prescribed treatment or a treatmenttime being unnecessarily extended. When a patient receives less than 90%of a dialysate treatment, it may be considered ineffective.

It is with respect to these and other considerations that the presentimprovements may be useful.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to necessarily identify keyfeatures or essential features of the claimed subject matter, nor is itintended as an aid in determining the scope of the claimed subjectmatter.

According to an exemplary embodiment of the present disclosure, a methodfor a dialysis treatment by a dialysis machine may include delivering avolume of dialysate with the dialysis machine to a patient, anddetecting a temperature of the dialysate volume, an air content of thedialysate volume, or another condition, or combinations thereof, whereinthe detected temperature of the dialysate volume is compared to apredetermined maximum temperature, the detected air content of thedialysate volume is compared to a predetermined maximum air content, orthe detected other condition generates a signal, or combinationsthereof. The method may further include diverting the volume ofdialysate in response to the detected temperature exceeding thepredetermined maximum temperature, the air content exceeding thepredetermined maximum air content, or the other condition generatedsignal, or combinations thereof. The method may further includetransferring the diverted volume of dialysate to the patient at a laterpoint during the dialysis treatment.

According to an exemplary embodiment of the present disclosure, adialysis system for conducting a dialysis treatment may include adialysis machine for transferring dialysate to a patient. The dialysismachine may be configured to flow the dialysate, and detect for a volumeof the dialysate, a temperature of the dialysate volume, an air contentof the dialysate volume, or another condition, or combinations thereof,wherein the detected temperature of the dialysate volume is compared toa predetermined maximum temperature, the detected air content of thedialysate volume is compared to a predetermined maximum air content, orthe detected other condition generates a signal, or combinationsthereof. The dialysis machine may further be configured to divert thevolume of dialysate in response to the detected temperature exceedingthe predetermined maximum temperature, the air content exceeding thepredetermined maximum air content, or the other condition generatedsignal, or combinations thereof. The dialysis machine may further beconfigured to transfer the diverted volume of dialysate to the patientat a later point during the dialysis treatment.

According to an exemplary embodiment of the present disclosure, a methodfor minimizing dialysate waste during treatment by a dialysis system mayinclude detecting (i) a temperature of a dialysate volume, wherein thedetected temperature of the dialysate volume is compared to apredetermined maximum temperature. The method may further includedetecting (ii) an air content of the dialysate volume, wherein thedetected air content of the dialysate volume is compared to apredetermined maximum air content. The method may further includedetecting (iii) another condition of the treatment, wherein the detectedother condition generates a signal. The method may further includedetecting any combinations of (i), (ii) and (iii). The method mayfurther include diverting the volume of dialysate in response to (vi)the detected temperature exceeding the predetermined maximumtemperature, (v) the air content exceeding the predetermined maximum aircontent or (vi) the other condition generated signal. The method mayfurther include diverting in response to any combinations of (iv), (v)and (vi). In various of the foregoing and other embodiments of thepresent disclosure, the other condition may include detecting a newtreatment set of a cartridge and tubing, priming the tubing, ordetecting a treatment event alarm or flow stop, or combinations thereof.

In various of the foregoing and other embodiments of the presentdisclosure, the volume of dialysate may be delivered from a dialysatebag to the dialysis machine via a heater bag, the heater bag beingdisposable on a top surface of the dialysis machine, such that thevolume of dialysate is heatable by batch in the heater bag. In variousof the foregoing and other embodiments of the present disclosure, thevolume of dialysate may be delivered from a dialysate bag to thedialysis machine via a warmer pouch. The warmer pouch is in-line withthe dialysis machine, the warmer pouch being configured such thatdialysate is continuously flowable through the warmer pouch.

In various of the foregoing and other embodiments of the presentdisclosure, the diverted volume of dialysate may be transferred to thepatient at a later point during the dialysis treatment. The divertedvolume of dialysate may be deliverable to the patient after delivery ofdialysate from all dialysate bags. The diverted volume of dialysate maybe deliverable to the patient in response to the detected temperaturebeing below the predetermined maximum temperature, the air content beingbelow the predetermined maximum air content, or the other condition isacceptable, or combinations thereof.

In various of the foregoing and other embodiments of the presentdisclosure, the volume of dialysate may be diverted to a dialysatecontainer. The dialysate container may be an additional holdingreservoir, an unused dialysate bag, or a used dialysate bag, orcombinations thereof. In various of the foregoing and other embodimentsof the present disclosure, the dialysis machine may be configured toactively cool the diverted volume of dialysate. In various of theforegoing and other embodiments of the present disclosure, the dialysismachine may be configured to provide an active measurement of thediverted volume of dialysate. In various of the foregoing and otherembodiments of the present disclosure, the other condition may includedetecting a new treatment set of a cartridge and tubing, priming thetubing, or detecting a treatment event alarm or flow stop, orcombinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

By way of example, specific embodiments of the disclosed methods anddevices will now be described, with reference to the accompanyingdrawings, in which:

FIG. 1 illustrates an exemplary embodiment of a dialysis machine in adialysis system configured in accordance with the present disclosure;

FIG. 2 illustrates another exemplary embodiment of a dialysis machine inaccordance with the present disclosure;

FIG. 3 is a block diagram illustrating an exemplary embodiment of adialysis machine controller in accordance with the present disclosure;

FIGS. 4A-4B illustrate exemplary embodiments of dialysis systems andmethods for waste minimization of dialysis solution in accordance withthe present disclosure;

FIG. 5 is a flow diagram illustrating an exemplary embodiment of adialysate system and method for waste minimization of dialysis solutionfor a dialysis machine in accordance with the present disclosure; and

FIG. 6 is a flow diagram illustrating another exemplary embodiment of adialysate system and method for waste minimization of dialysate solutionfor a dialysis machine in accordance with the present disclosure.

DETAILED DESCRIPTION

The present embodiments will now be described more fully hereinafterwith reference to the accompanying drawings, in which several exemplaryembodiments are shown. The subject matter of the present disclosure,however, may be embodied in many different forms and types of methodsand devices for dialysis machines and other potential medical devicesand treatments, and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and willfully conveythe scope of the subject matter to those skilled in the art. In thedrawings, like numbers refer to like elements throughout.

Exemplary embodiments of dialysis machines and of methods for operatingdialysis machines may minimize potential dialysate waste, e.g., so apatient may receive a fuller prescribed treatment, treatment times maybe efficient, and use of the valuable treatment resources may beconserved and optimized to the benefit of the patient, hospital,dialysis centers, environment, etc. As described above, each dialysatebag may contain a volume of air (e.g., air content), which may bepresent as a result of the bag being not completely filled withdialysate during manufacture. Additionally, dialysate bags may be storedfor a period of time prior to sale and/or use by a patient, e.g., 1-2years or longer. Certain bag materials may be more susceptible toosmosis, for example, a Biofine™ material bag may have a greater volumeof air content after a period of storage than a bag made of a differentmaterial, such as a polyvinyl chloride (PVC) material. For example, abag may contain a range of approximately 20 cc to 150 cc of air.Although the term “bag” is used throughout, it should be understood thata dialysate bag may be any type of container capable of holding a fluid,e.g., a dialysate. In some embodiments, a fluid container may include acontainer in which dry concentrates are mixed with water to generatedialysate suitable for a dialysis treatment.

To ensure patient comfort and to efficiently receive the proper amountof dialysis treatment, air content in a dialysis treatment may beminimized by sensor detection and alarms. Additionally, a dialysissystem may be primed, so that at a beginning of a treatment or beginningof delivery from each dialysate bag, prior to delivery of dialysate to apatient, a predetermined amount (e.g., 50 mL to 100 mL) of dialysate maybe purged from the system so as to purge any air, for example, aircontent in the tubing and/or a pump cassette and/or initial air bubblesin dialysate bags/lines. This initial purge, or flush, may also help toremove potential contaminants that may be introduced at connections,e.g., between the bags and the lines, by flowing dialysate in adirection from the dialysate bag to the drain. When a predeterminedvolume of air is detected in the dialysate during treatment, or thesystem is primed, the dialysis machine may be configured to purge ordrain waste instead of flowing the dialysate into a patient.

Heating the dialysate may present difficulties with managing temperaturefluctuations in the dialysate (e.g., FIGS. 1-2), as well. For example,in dialysis machines having an internal heating element to heat acontinuous flow of dialysate through a warmer pouch, if dialysateremains in or alongside a heating element for a time period longer thandesired, such as if a kink in the tubing slows flow of dialysate throughor by the heating element, the dialysate may become overheated (e.g.,above approximately 98°-100° F., 37° C.). If the dialysate isoverheated, it may be prevented from flowing into a patient so as toprevent discomfort or potential burning or other harmful effects. Insome embodiments, if the dialysate is underheated (e.g., approximately25° C.-33° C.), it may also be prevented from flowing into a patientuntil it has heated up to the desired temperature. For example, in batchheating embodiments a dialysate transfer may be delayed until thedialysate has been heated to a predetermined temperature. In in-lineheating embodiments, underheated dialysate may be diverted and/orpurged.

When air content is present in the dialysate or system, or the dialysateis at an unacceptable temperature, or another treatment event conditionoccurs where it is necessary for flow to the patient to be temporarilypaused, the dialysate may be “temporarily unusable” for flowing into apatient. When temporarily unusable dialysate is dumped to drain,dialysate that was prescribed to the patient is wasted. Each event oftemporarily unusable dialysate may result in a range of approximately 30mL to 100 mL of dialysate being drained instead of flowing into apatient. As one to several events may occur in a single treatment, thiswasted dialysate may result in a patient not receiving as full aprescribed treatment as might be possible, and treatment time and use ofresources may not be optimal. It may therefore be advantageous asdescribed herein to improve dialysate flow management to minimize oreliminate waste by instead of purging dialysate, diverting the temporaryunusable dialysate to a dialysate container whereby it may betransferred to the patient for use later in the treatment.

FIG. 1 shows an example of a dialysis system 100 (e.g., a peritonealdialysis (PD) system) that is configured in accordance with an exemplaryembodiment of the system described herein. In some implementations, thedialysis system 100 may be configured for use at a patient's home (e.g.,a home PD system). The dialysis system 100 may include a dialysismachine 102 (e.g., a peritoneal dialysis machine 102, also referred toas a PD cycler) and in some embodiments the machine may be seated on acart 104. The dialysis machine 102 may include a housing 106, a door108, and a cartridge interface for contacting a disposable cassette, orcartridge, where the cartridge is located within a compartment formedbetween the cartridge interface and the closed door 108. A heater tray116 may be positioned on top of the housing 106. The heater tray 116 maybe any size and shape to accommodate a bag of dialysate (e.g., a 5 L bagof dialysate) for batch heating. The dialysis machine 102 may alsoinclude a user interface such as a touch screen 118 and control panel120 operable by a user (e.g., a caregiver or a patient) to allow, forexample, set up, initiation, and/or termination of a dialysis treatment.

Dialysate bags 122 may be suspended from hooks the sides of the cart104, and a heater bag 124 may be positioned in the heater tray 116.Hanging the dialysate bags 122 may improve air management as air contentmay be disposed by gravity to a top portion of the dialysate bag 122.Although four dialysate bags 122 are illustrated in FIG. 1, any numberof dialysate bags may be connectable to the dialysis machine 102 (e.g.,1 to 5 bags, or more), and reference made to first and second bags isnot limiting to the total number of bags used in a dialysis system 100.For example, the dialysis machine may have dialysate bags 122 a, . . .122 n connectable in the system 101. In some embodiments, connectors andtubing ports may connect the dialysate bags 122 and lines fortransferring dialysate. Dialysate from the dialysate bags 122 may betransferred to the heater bag 124 in batches. For example, a batch ofdialysate may be transferred from the dialysate bags 122 to the heaterbag 124, where the dialysate is heated by the heating element. When thebatch of dialysate has reached a predetermined temperature (e.g.,approximately 98°−100° F., 37° C.), the batch of dialysate may be flowedinto the patient. The dialysate bags 122 and the heater bag 124 may beconnected to the cartridge via dialysate bag lines or tubing 126 and aheater bag line or tubing 128, respectively. The dialysate bag lines 126may be used to pass dialysate from dialysate bags 122 to the cartridgeduring use, and the heater bag line 128 may be used to pass dialysateback and forth between the cartridge and the heater bag 124 during use.In addition, a patient line 130 and a drain line 132 may be connected tothe cartridge. The patient line 130 may be connected to a patient'sabdomen via a catheter and may be used to pass dialysate back and forthbetween the cartridge and the patient's peritoneal cavity during use.The drain line 132 may be connected to a drain or drain receptacle andmay be used to pass dialysate from the cartridge to the drain or drainreceptacle during use (see FIGS. 4A-4B).

The touch screen 118 and the control panel 120 may allow an operator toinput various treatment parameters to the dialysis machine 102 and tootherwise control the dialysis machine 102. In addition, the touchscreen 118 may serve as a display. The touch screen 118 may function toprovide information to the patient and the operator of the dialysissystem 100. For example, the touch screen 118 may display informationrelated to a dialysis treatment to be applied to the patient, includinginformation related to a prescription.

The dialysis machine 102 may include a processing module 101 thatresides inside the dialysis machine 102, the processing module 101 beingconfigured to communicate with the touch screen 118 and the controlpanel 120. The processing module 101 may be configured to receive datafrom the touch screen 118 the control panel 120 and sensors, e.g.,weight, air, flow, temperature, and/or pressure sensors, and control thedialysis machine 102 based on the received data. For example, theprocessing module 101 may adjust the operating parameters of thedialysis machine 102.

The dialysis machine 102 may be configured to connect to a network 110.The connection to network 110 may be via a wired and/or wirelessconnection. The dialysis machine 102 may include a connection component112 configured to facilitate the connection to the network 110. Theconnection component 112 may be a transceiver for wireless connectionsand/or other signal processor for processing signals transmitted andreceived over a wired connection. Other medical devices (e.g., otherdialysis machines) or components may be configured to connect to thenetwork 110 and communicate with the dialysis machine 102.

Referring now to FIG. 2, another exemplary embodiment of a dialysismachine 200 in accordance with the present disclosure is shown. Thedialysis machine 200 may be implemented in the peritoneal dialysissystem 100 and may be in lieu of the dialysis machine 102, and mayinclude, for example, a housing 206, a processing module 201, aconnection component 212, a touch screen 218, and a control panel 220operable by a user (e.g., a caregiver or a patient) to allow, forexample, set up, initiation, and/or termination of a dialysis treatment.The processing module 201 and the connection component 212 may beconfigured similarly to the processing module 101 and connectioncomponent 112 described above. However, instead of a heater tray for aheater bag and batch heating being positioned on a top surface 102 a ofthe housing as shown in FIG. 1, one or more heating elements may bedisposed internal to the dialysis machine 200. For example, a warmerpouch 224 may be insertable into an opening 210 in a direction indicatedat arrow 214. It is also understood that the warmer pouch 224 may beconnectable to the dialysis machine 200 via tubing, or fluid lines, viaa cartridge. The tubing may be connectable so that dialysate may flowfrom the dialysate bags 122, through the warmer pouch 224 for heating,and to the patient.

In such in-line heating embodiments, the warmer pouch 224 may beconfigured so dialysate may continually flow through the warmer pouch(instead of transferred in batches for batch heating) to achieve apredetermined temperature before flowing into the patient. For example,in some embodiments the dialysate may continually flow through thewarmer pouch 224 at a rate between approximately 100-300 mL/min.Internal heating elements (not shown) may be positioned above and/orbelow the opening 210, so that when the warmer pouch 224 is insertedinto the opening 210, the one or more heating elements may affect thetemperature of dialysate flowing through the warmer pouch 224. In someembodiments, the internal warmer pouch may instead be a portion oftubing in the system that is passed by, around, or otherwise configuredwith respect to, a heating element(s).

In some embodiments, a dialysis machine 102, 200 may provide an activemeasurement of the dialysate temperature in dialysate bags, heater bag,and/or the warmer pouch e.g., in the dialysate bags 122, the heater bag124, and/or the warmer pouch 224, or combinations thereof of FIGS. 1-2.It is understood that FIG. 1 illustrates that dialysate may betransferable to and stored in the heater bag 124 by “batch” untilreaching an acceptable temperature for use, and that FIG. 2 illustratesdialysate continuously flowing through the warmer pouch 224 “in-line”with the dialysis machine 200, reaching an acceptable temperature by theapplication of internal heating elements.

As described above, embodiments having an in-line warmer pouch 224 maybe more susceptible than embodiments utilizing batch heating totemperature variation of the dialysate. For example, if flow ratechanges during treatment, such as a kink in the tubing occurring or anobstruction on the inlet, dialysate may dwell in the warmer pouch 224for a longer time period and reach a higher than intended temperature.If dialysate is higher than approximately 41° C., or 105° F.-106° F., itmay not be delivered to the patient to ensure patient safety.

Referring to FIG. 3, a schematic of an exemplary embodiment of adialysis machine 300 and a controller 305 in accordance with the presentdisclosure are shown. The dialysis machine 300 may be a home dialysismachine, e.g., a peritoneal dialysis machine, for performing a dialysistreatment on a patient, and may be included in the system 100 fordialysis machines 102, 200, described above with respect to FIGS. 1-2and dialysis machine 102, 200. Additionally, components described withrespect to the dialysis machine 300 may also be included in the dialysismachines 102, 200. A power source 325 may provide power and/or aconnection to an external power source to the dialysis machine 102, 200,300, 405, 455.

The controller 305 may automatically control execution of a treatmentfunction during a course of dialysis treatment. For example, thecontroller 305 may control the delivery and transfer of dialysate asshown in FIGS. 4A-4B and FIG. 5 for dialysis machines 102, 200, 300,405, 455. The controller 305 may be operatively connected to sensors 340and deliver one or more signals to execute one or more treatmentfunctions, or a course of treatment associated with various treatmentsystems. For example, dialysis treatment may include transferringdialysate from the dialysate bag 122 to the heater bag 124 and then tothe patient, or delivering dialysate from the dialysate bag 122 throughthe warmer pouch 224 to the patient), or a course of treatmentassociated with various treatment systems. In some embodiments, a timer355 may be included for timing triggering of sensors 340. It isunderstood that sensors, including but not limited to pressure sensors,weight sensors, flow sensors, air sensors, and temperature sensors, maydetect dialysate temperature, fluid volume, air content, fluid flowrate, and fluid flow pressure for the dialysis machine 102, 200, 300,405, 455 to determine flow delivery to and from the patient. Forexample, the dialysis machine 102, 200, 300, 405, 455 may include aplurality of sensors for detection and/or measurement of any combinationof temperature, pressure, volume, air content, fluid flow. Multiplesensors may also be included to detect and/or measure individually thetemperature, pressure, volume, air content, fluid flow.

In some embodiments, the controller 305, processor 310, and/or memory320 of the dialysis machine 300 may receive sensor 340 signalsindicating complete dialysate transfer of the dialysate bags, andindicating process parameters, such as temperature, pressure, aircontent, volume, flow rate, and the like. When either temperature and/orair content of the dialysate is at an unacceptable level, the controller305, processor 310, and/or memory 320 may divert the temporarilyunusable dialysate into a temporary holding container (e.g., analternative dialysate bag) to be delivered to the patient later in thetreatment. For example, each dialysate bag (e.g., the dialysate bags 122and the heater bag 124) may contain an approximate amount of dialysate,such that “approximate amount” may be defined as a 3 L dialysate bagcontaining 3000 to 3150 mL, a 5 L dialysate bag containing 5000 to 5250mL, and a 6 L dialysate bag containing 6000 to 6300 mL. Although bagvolume is described herein as 3 L, 5 L and 6 L, it is understood thatthe specified volumes are only exemplary and bag volume may be anyvolume, and an “approximate” volume may be in a range within 10% of thedesired volume. The controller 305 may also detect connection of alldialysate bags 122 connected. The controller 305 may monitor thedialysate bags 122 for dialysate transfer, so that the controller 305knows the volume of dialysate that has been transferred from eachdialysate bag 122, and if dialysate has been diverted to a dialysate bag122 as a temporary holding container.

Communication between the controller 305 and the treatment system may bebi-directional, whereby the treatment system acknowledges controlsignals, and/or may provide state information associated with thetreatment system and/or requested operations. For example, system stateinformation may include a state associated with specific operations tobe executed by the treatment system (e.g., trigger pump to deliverdialysate, trigger pumps and/or compressors to deliver filtered blood,and the like) and a status associated with specific operations (e.g.,ready to execute, executing, completed, successfully completed, queuedfor execution, waiting for control signal, and the like).

In embodiments, the dialysis machine 102, 200, 300 may include at leastone pump 350 operatively connected to the controller 305. During atreatment operation, the controller 305 may control the pump 350 forpumping fluid, e.g., fresh and spent dialysate, to and from a patient.The pump 350 may also pump dialysate from the dialysate bag 122 to theheater bag 124, or to another dialysate bag 122. In embodiments wherethe warmer pouch 224 is in-line with the dialysis machine 200, the pump350 may pump the dialysate through the warmer pouch 224 directly to thepatient. The controller 305 may also be operatively connected to aspeaker 330 and a microphone 335 disposed in the dialysis machine 300. Auser input interface 315 may include a combination of hardware andsoftware components that allow the controller 305 to communicate with anexternal entity, such as a patient or other user, and a display 302 maydisplay information to the user or medical professional. Thesecomponents may be configured to receive information from actions such asphysical movement or gestures and verbal intonation. For example, thepatient may enter via the user input interface 315 sizes of thedialysate bags 122 for use in treatment. In embodiments, the componentsof the user input interface 315 may provide information to externalentities. Examples of the components that may be employed within theuser input interface 315 include keypads, buttons, microphones, touchscreens, gesture recognition devices, display screens, and speakers. Thedialysis machine 102, 200, 300 may also be wirelessly connectable viathe antenna 345 for remote communication.

As shown in FIG. 3, sensors 340 may be included for monitoring one ormore parameters and may be operatively connected to at least thecontroller 305, processor 310, and memory 320. The processor 310 may beconfigured to execute an operating system, which may provide platformservices to application software, e.g., for operating the dialysismachine 300. These platform services may include inter-process andnetwork communication, file system management and standard databasemanipulation. One or more of many operating systems may be used, andexamples are not limited to any particular operating system or operatingsystem characteristic. In some examples, the processor 310 may beconfigured to execute a real-time operating system (RTOS), such asRTLinux, or a non-real time operating system, such as BSD or GNU/Linux.

According to a variety of examples, the processor 310 may be acommercially available processor such as a processor manufactured byINTEL, AMD, MOTOROLA, and FREESCALE. However, the processor 310 may beany type of processor, multiprocessor or controller, whethercommercially available or specially manufactured. For instance,according to one example, the processor 310 may include an MPC823microprocessor manufactured by MOTOROLA.

The memory 320 may include a computer readable and writeable nonvolatiledata storage medium configured to store non-transitory instructions anddata. In addition, the memory 320 may include a processor memory thatstores data during operation of the processor 310. In some examples, theprocessor memory includes a relatively high performance, volatile,random access memory such as dynamic random access memory (DRAM), staticmemory (SRAM), or synchronous DRAM. However, the processor memory mayinclude any device for storing data, such as a non-volatile memory, withsufficient throughput and storage capacity to support the functionsdescribed herein. Further, examples are not limited to a particularmemory, memory system, or data storage system.

The instructions stored on the memory 320 may include executableprograms or other code that may be executed by the processor 310. Theinstructions may be persistently stored as encoded signals, and theinstructions may cause the processor 310 to perform the functionsdescribed herein. The memory 320 may include information that isrecorded, on or in, the medium, and this information may be processed bythe processor 310 during execution of instructions. The memory 320 mayalso include, for example, specification of data records for user timingrequirements, timing for treatment and/or operations, and historicsensor information. The medium may, for example, be optical disk,magnetic disk or flash memory, among others, and may be permanentlyaffixed to, or removable from, the controller 305.

A pressure sensor may be included for monitoring fluid pressure of thedialysis machine 102, 200, 300, although the sensors 340 may alsoinclude any of a heart rate sensor, a respiration sensor, a temperaturesensor, a flow sensor, a weight sensor, a video sensor, an air sensor,an air bubble sensor, a thermal imaging sensor, an electroencephalogramsensor, a motion sensor, audio sensor, an accelerometer, or capacitancesensor. In some embodiments, a flow sensor may detect and/or measure aflow of dialysate, e.g., to measure the dialysate transferred from thefirst and second bags to the patient. In some embodiments, a flow sensormay also detect and/or measure a flow of dialysate through the warmerpouch 224, or to the heater bag 124. It is appreciated that the sensors340 may include sensors with varying sampling rates, including wirelesssensors.

The controller 305 may be disposed in the dialysis machine 102, 200, 300or may be coupled to the dialysis machine 102, 200, 300 via acommunication port or wireless communication links, shown schematicallyas communication element 306 (see FIG. 3). According to variousexamples, the communication element 306 may support a variety of one ormore standards and protocols, examples of which include USB, WiFi,TCP/IP, Ethernet, Bluetooth, Zigbee, CAN-bus, IP, IPV6, UDP, UTN, HTTP,HTTPS, FTP, SNMP, CDMA, NMEA and/or GSM. As a component disposed withinthe dialysis machine 300, the controller 305 may be operativelyconnected to any one or more of the sensors 340, pump 350, orcombinations thereof. The controller 305 may communicate control signalsor triggering voltages to the components of the dialysis machine 102,200, 300. As discussed, exemplary embodiments of the controller 305 mayinclude wireless communication interfaces. The controller 305 may detectremote devices to determine if any remote sensors are available toaugment any sensor data being used to evaluate the patient.

Referring now to FIGS. 4A, 4B, and FIG. 5, an exemplary embodiment of amethod for minimizing dialysate waste in accordance with the presentdisclosure is shown. FIG. 4A illustrates a dialysis system 400 includinga dialysis machine 405 similar to the dialysis machine 102 in FIG. 1,including a heater bag 124 disposed on a heating element on a top of thedialysis machine 405. FIG. 4B illustrates a dialysis system 450including a dialysis machine 455 similar to the dialysis machine 200 inFIG. 2, where the warmer pouch 224 is in-line with the dialysis machine455. FIG. 5 shows an exemplary embodiment of a flow diagram of a method500 for operating a dialysis machine, with a treatment beginning at step505.

During treatment, a volume of dialysate may enter the patient's abdomenand remain for a period of time, e.g., a dwell time. During the dwelltime, the dialysate may cause flow across the peritoneum ofcontaminants/toxins and/or particulates from a patient's blood andexchange substances and fluids (e.g., electrolytes, urea, glucose,albumin, osmotically active particles, and other small molecules). Atthe end of the dwell time, the used dialysate, ultrafiltrate, and/orcontaminants/toxins may be flowed out of the patient's abdomen andpurged to a drain 410 connected to the tubing 420, e.g., the drain line132, indicated by arrow 440 and illustrated in dash-lines. This exchangeof fresh dialysate and used dialysate after a dwell time may occur forseveral cycles depending on the patient's treatment regimen.

Both embodiments illustrated in FIGS. 4A and 4B may include dialysatecontainers 425, which in some embodiments may be dialysate bags 122 (seeFIG. 1), where dialysate transfer between the respective dialysismachine and the dialysate bags 122 may be similar. In some embodiments,the dialysate container 425 may be an additional holding reservoir. Theadditional holding reservoir may be any type of a container, e.g., abag, or other configuration for retaining dialysate, and/or forreceiving diverted dialysate for later use in the treatment. In someembodiments, an additional holding reservoir may be configured in asimilar manner to the dialysate bags 122. The additional holdingreservoir, separate from the dialysate bags, may prevent mixing diverteddialysate with undelivered dialysate, although a separate additionalholding reservoir may be optional. In some embodiments, separateadditional holding reservoir may be advantageous to isolate detected airfrom dialysate. For example, diverting back into a dialysate bag 122 mayreintroduce air for detection later in the treatment. Three dialysatecontainers 425 are shown merely for illustrative purposes, and it isunderstood that a treatment regimen may need more or less dialysate bags122, and other dialysate containers may be connected to the dialysismachine 405, 455. It is understood that the individual patient treatmentregimen and total dialysate volume in each bag may dictate how manydialysate bags 122 and/or other dialysate containers are connected tothe dialysis machine 405, 455. For example, dialysate bags 122 maycontain the same volume of dialysate, or a different volume ofdialysate. Dialysate bags 122 may be sized to contain approximately 3 L,5 L, and/or 6 L of dialysate. If a patient treatment regimen calls for 9L total of dialysate, a patient may connect a 6 L dialysate bag and a 3L dialysate bag to the dialysis machine 102. A dialysis treatment mayinclude approximately 3 L-30 L of dialysate and may connect up to fivebags to deliver the prescribed treatment.

At step 510, a volume of dialysate may be delivered to a patient. Forexample, dialysate may be delivered into the patient after being heatedto a predetermined temperature via tubing 420. In batch heatingembodiments, the dialysate may flow into the patient after heating to apredetermined temperature in the heater bag 124. In in-line heatingembodiments, the dialysate may flow directly from dialysate bags to thepatient by continuously flowing through the warmer pouch. The warmerpouch 224 may have a pathway for the dialysate to flow through, e.g., atortuous or circuitous flow path, so that the dialysate may reach thepredetermined temperature by the time the dialysate exits the flow pathto continue into the patient. The dialysate may be heated up from roomtemperature to body temperature (approximately 98° F.-100° F., 37° C.)by batch or in-line heating, as described above. In some embodiments,tubing 420 may be fluid lines connecting a patient to the dialysissystem via a cartridge, including but not limited to a dialysate baglines 126, a heater bag line 128, a patient line 130, and a drain line132. Additionally, it is also understood that for each treatmentprocedure, the patient receives a sterilized and disposable “set,”including but not limited to tubing, a cartridge, dialysate bags, andthe like. After each treatment, each “set” may be disposed of tominimize any potential contamination.

In embodiments, a volume of dialysate may be transferrable by batch tothe heater bag 124 via the tubing 420 for heating before flowing intothe patient, as shown in FIG. 4A and indicated by arrow 430. In otherembodiments, a volume of dialysate may be transferrable through thewarmer pouch 224 in-line with the dialysis machine 200 for heatingbefore flowing into the patient, as shown in FIG. 4B and indicated byarrow 460. When the heater bag 124 is disposed above the dialysismachine 405 as illustrated in FIG. 4A, a batch of dialysate may flowfrom the heater bag 124 to the machine 405 indicated by arrow 435, e.g.,to the cartridge for pumping into the patient. In other embodiments, asillustrated in FIG. 4B, when the warmer pouch 224 is in-line with thedialysis machine 455, extra steps may not be needed to flow thedialysate to the machine 455.

In some embodiments, e.g., illustrated in FIG. 4A, the dialysis machine102, 405 may transfer an amount equal to a fill volume or a volume ofthe heater bag 124, plus an additional predetermined amount (e.g., 300mL) in order to ensure sufficient dialysate volume for the next fill.However, air content may still be present in the heater bag 124. Forexample, the heater bag 124 may lie flat on the top surface 102 a of thedialysis machine 102, 300, 405, 455 such that an air content containedin the heater bag 124 may migrate toward a side of the bag, possiblynear a connection point 415 of the tubing 420. Some embodiments mayaccount for this by tilting the top surface 102 a, skewing the heaterbag 124 to having a tubing connector at the lowest side to minimize aircontent (as air may flow up to an upper portion of the heater bag 124).However, this may not account for user set-up variability, e.g., homeuse possibly utilizing uneven surfaces. An alert or alarm, or multiplealerts or alarms, may be triggered by a detected air content even thougha sufficient amount of dialysate is present.

At step 515, the dialysis machine 102, 200, 300, 405, 455 may determinewhether a temperature of the dialysate is acceptable for delivery to thepatient. In embodiments, a sensor 340 (e.g., a temperature sensor) maydetect the dialysate temperature, and the processor 310 may compare thedetected dialysate temperature to a predetermined maximum temperature.For example, the predetermined maximum temperature may be approximately41° C. At step 520, the dialysis machine 102, 200, 300, 405, 455 maydetermine whether an air content (e.g., volume of air) is detected inthe dialysate, and compare the detected air content to a predeterminedmaximum air content. In embodiments, another sensor 340 may detect airbubbles, a fluid pressure, or other value to determine if anunacceptable level of air is present. Unacceptable levels of air contentmay affect patient comfort during or after treatment.

If the dialysate temperature is acceptable at step 515, and/or anacceptable volume of air is detected in the dialysate at step 520, thedialysis machine 102, 200, 300, 405, 455 may determine if anothercondition has been detected that may necessitate dialysate diversion atstep 530. This other condition may include detecting a new treatment setof a cartridge and tubing, priming the tubing, or detecting a treatmentevent alarm or flow stop, or combinations thereof. It is understood thatthe other condition may be an individual condition, multiples of anindividual condition, or a combination of the conditions. In someembodiments, when a new treatment set of disposable bags, lines,cartridge, and the like, is introduced in the dialysis machine 102, 200,300, 405, 455, the set may need to be primed, e.g., dialysate is flowedthrough to remove initial air content, to verify valves and connections,and the like. This may be a condition that generates an automatic signalwhen the new set is connected, for the dialysis machine to prime theset, or a user may manually initiate priming upon completion of set-up.In some embodiments, an event may occur during treatment, including butnot limited to a kink in the tubing 420, a leak is detected, acontamination is detected, or combinations thereof, which may deviatefrom treatment protocol. It is understood that these events may beindividual, or in combination with each other, or multiples of eachevent. In some embodiments, the treatment flow into the patient may bepaused or stopped, and an alarm may signal to the user and/or a remotesource, although dialysate may still be flowing through the set oftubing and the cartridge, and may still be heating. If no othercondition is detected, then dialysate may be flowed into the patient atstep 535. If another condition is detected, a condition signal may begenerated and in response to the condition signal, the dialysate, adialysate volume may be diverted as described below with respect to step525.

It should be understood that steps 515, 520, and 530 may be performed inany order, or simultaneously, and may not be dependent on the outcome ofthe other. In embodiments, the dialysis machine 102, 200, 300, 405, 455may perform only step 515 or multiple steps 515, only step 520 ormultiple steps 520, only step 530 or multiple steps 530, or acombination of step 515, 520, and 530 or a combination of multiple steps515, 520, and 530.

If a comparison of the detected dialysate temperature is above apredetermined temperature (e.g., approximately 41° C.) at step 515, acomparison of the air volume (e.g., air content) detected at step 520 isabove a predetermined maximum air content, and/or another condition isdetected to generate a signal (e.g., priming the set, a treatment eventoccurs), then the temporarily unusable dialysate volume may be divertedat step 525. In some embodiments, the volume of dialysate may betransferred to a dialysate container. For example, a dialysate container425 may be dialysate bags 122, which may be unused dialysate bags fromwhich dialysate has not yet been transferred or a used dialysate bag, orboth, from which the dialysate has been transferred, where diverteddialysate is held in a dialysate bag 122 not currently being used by thedialysis machine 102, 200, 300, 405, 455. The dialysate container 425may be an additional holding reservoir, separate from the dialysate bags122 and configured for receiving diverted dialysate. The dialysatecontainer 425 may act as a holding reservoir for diverted dialysate andallow the temporarily unusable dialysate to later be used in thetreatment. For example, overheated dialysate may have time to cool (ormay be actively cooled) to a temperature acceptable for delivering tothe patient. Additionally, air bubbles may be allowed to converge andflow to an upper portion of the dialysate bag so that air contentdelivered may be minimized. The dialysis machine 102, 200, 300, 405, 455may later be able to transfer the now-usable dialysate from thedialysate container 425 to the patient.

In some embodiments, the dialysate may passively cool to an acceptabletemperature in the dialysate container 425, e.g., room temperature,through the course of treatment, although in other embodiments, thedialysis system may include an active cooling mechanism for theoverheated dialysate. For example, the dialysate container 425 may bedisposed adjacent to or coupled with an active cooling mechanism toactively lower the temperature of the diverted dialysate. The activecooling mechanism may include any one or a combination of a heatexchanger, a cooling element, a fan, a thermoelectric cooler (TEC), orthe like.

In some embodiments, if the dialysate volume is diverted only forexceeding a predetermined temperature, the diverted dialysate may beflowed through an active cooling mechanism to lower the temperature ofthe dialysate, and then flowed to the patient. Instead of storing thediverted dialysate in a separate container, the dialysis system maycontinue to flow the diverted dialysate in parallel with dialysateflowing to the patient (e.g., via tubing 420) to the active coolingmechanism. Once the diverted dialysate is an acceptable temperature, thediverted dialysate may then be rejoined with dialysate flowing to thepatient.

In embodiments, when dialysate is diverted from a first dialysate bag,the diverted dialysate may be transferred any other dialysate bag inwhich dialysate is not being immediately drawn or from which alldialysate has already been drawn, or which is specially designated as aholdover reservoir for diverted dialysate volumes. For example, FIG. 4Aillustrates arrow 445 diverting dialysate into the farthest (from thedialysis machine 405) dialysate container 425 while dialysate is beingdrawn from the nearest (to the dialysis machine 405) dialysate container425. Similarly, FIG. 4B illustrates arrow 465 diverting dialysate intothe farthest (from the dialysis machine 455) dialysate container 425while dialysate is being drawn from the nearest (to the dialysis machine455) dialysate container 425.

In embodiments, the dialysis machine 102, 200, 300, 405, 455 may beconfigured to monitor which dialysate container 425 is flowingdialysate, and determine the dialysate container 425 to diverttemporarily unusable dialysate. The diverted dialysate may be divertedto a single dialysate container 425, or a combination of multipledialysate containers 425. In some embodiments, the dialysate container425 to receive the diverted dialysate may be initially empty ofdialysate, although in some embodiments, a volume of dialysate may bepresent. It may not be disadvantageous to mix, as fresh dialysate anddiverted dialysate may be of the same concentrations. For example, inbatch heating embodiments, dialysate from different dialysate containers425 may be flowed into the heater bag 124, where it mixes togetherbefore flowing into the patient.

If the dialysate temperature is acceptable at step 515, no air contentor an acceptable volume of air is detected in the dialysate at step 520,and/or no other condition is detected at step 530, the treatment maycontinue at step 535, exchanging fresh dialysate and used dialysateafter a dwell time for a number of cycles dependent on the patient'streatment regimen. Dialysate may be transferred from all of thedialysate containers 425 (e.g., dialysate bags 122, heater bag 124,and/or warmer pouch 224, and dialysate container) connected to thedialysis machine 102, 200, 300, 405, 455 to complete a treatment. Forexample, in embodiments, the dialysis machine 102, 200, 300, 405, 455may determine if the diverted dialysate volume is acceptable for use atstep 540. A temperature sensor 340 may detect the temperature of thediverted dialysate, and a sensor 340 (e.g., a pressure sensor and/orweight sensor) may determine the air content present in the diverteddialysate volume. Other sensors 340, or a combination of temperature,pressure, weight, flow, and other sensors 340 may also be used in thedialysis machine 102, 200, 300, 405, 455 for detecting and monitoringthe dialysate. If the diverted dialysate is acceptable for use, thedialysate volume may be delivered to the patient as in step 510. If thediverted dialysate volume is not acceptable for transfer to the patient,e.g., the dialysate temperature still exceeds approximately 41° C., anair content exceeds a predetermined maximum air content, then at step555 the dialysis machine 102, 200, 300, 405, 455 may continue to holdthe diverted dialysate volume and deliver dialysate from othernon-diverted sources, e.g., dialysate bags 122. In embodiments, thedialysis machine 102, 200, 300, 405, 455 may include a timer 355 orother timing function to periodically check the diverted dialysatevolume for acceptability. The timer 355 may be a predetermined timeperiod, e.g., the diverted dialysate may be monitored in 5 or 10 minuteintervals. In some embodiments, the diverted dialysate volume may bechecked prior to diverting additional dialysate.

By diverting the temporarily unusable dialysate (e.g., overheated,containing air content or excess air content, initial dialysate flow forpriming) to a dialysate container 425, it may be usable later in thetreatment, thereby minimizing wasted dialysate. The dialysis machine102, 200, 300, 405, 455 may determine at step 545 whether an entiredialysate treatment has been delivered to the patient. For example, thedialysis machine 102, 200, 300, 405, 455 may monitor levels of dialysatein all of the dialysate containers 425 throughout the treatment. Forexample, dialysate bags 122 may be completely transferred, either to thepatient, or diverted to a dialysate container 425. As mentioned,multiple dialysate bags may be connectable to the dialysis machine 102,200, 300, 405, 455 for delivering a prescribed treatment to a patient.Each dialysate bag may be transferred to the patient as described inco-pending application filed concurrently, entitled “Automatic DialysateDetection in Dialysis Machines” to Plahey et al., which is hereinincorporated by reference in its entirety.

If dialysate is diverted back into one of the dialysate bags 122, thedialysis machine 102, 200, 300, 405, 455 may ensure that the diverteddialysate may be delivered to the patient before the treatment ends atstep 550, thereby ensuring the patient receives a more completeprescribed treatment. In embodiments where an additional holdingreservoir is included, the dialysis machine 102, 200, 300, 405, 455 mayfirst transfer dialysate from all of the dialysate bags 122. Asdescribed above, at step 540, if temporarily unusable dialysate wasdiverted to the additional holding reservoir, the dialysis machine 102,200, 300, 405, 455 may determine if the temperature and air content areat acceptable levels so that the diverted dialysate may then bedelivered to the patient.

Referring now to FIG. 6, another exemplary embodiment of a system andmethod of delivering dialysate is shown. It is understood that steps605, 610, 615, 620, 630, 635, 645, and 650 are identical to steps 505,510, 515, 520, 530, 535, 545, and 550, respectively, as described above.In the flow diagram 600 of FIG. 6, instead of flowing the diverteddialysate as it is determined to be acceptable (e.g., decreases to anacceptable temperature), the diverted dialysate may be used after allthe dialysate from dialysate bags 122 has been delivered to the patient.

As described above, if the dialysate temperature is above apredetermined temperature, e.g., 41° C. at step 615, if air is detectedin the dialysate at step 620, or another condition has been detected atstep 630, the volume of dialysate may be diverted at step 625. Asmentioned, the dialysate may be diverted to an additional holdingreservoir, or an unused dialysate bag, or a used dialysate bag, orcombinations thereof. For example, the dialysis machine 102, 200, 300,405, 455 may determine where to divert the dialysate based on thetreatment cycle. When the dialysate has been diverted, the process maycontinue by returning to step 610, delivering another volume ofdialysate to the patient, e.g., another cycle.

At step 645, the dialysis machine 102, 200, 300, 405, 455 may determineif the entire dialysate treatment has been delivered to the patient. Ifthe total treatment volume has not been delivered to the patient, atstep 655, the dialysis machine 102, 200, 300, 405, 455 may determine ifthe diverted dialysate is acceptable to flow into the patient, e.g., thediverted dialysate may be at an acceptable temperature for use. Aircontent may also converge to reduce air bubbles so less air may bedelivered to the patient. If the dialysate is acceptable for thepatient, the dialysis machine may continue by delivering the diverteddialysate at step 610. If the diverted dialysate is not acceptable forthe patient to receive, the dialysis machine 102, 200, 300, 405, 455 mayalarm. If a treatment volume delivered to the patient is less than apredetermined percentage of the total treatment volume, the dialysismachine 102, 200, 300, 405, 455 may alarm and may shut down withoutdelivering any additional dialysate. For example, if the treatmentvolume delivered is less than 90% of the total treatment volume, thedialysis machine 102, 200, 300, 405, 455 may alarm or alert a user ormedical professional that the treatment may be ineffective. In someembodiments, if a treatment volume delivered to the patient is less thana predetermined percentage of the total treatment volume, but greaterthan a minimum percentage of the total treatment volume, the dialysismachine may complete treatment but also generate an alarm or alert tonotify the user or medical professional of the total treatment. Forexample, if the treatment volume delivered is greater than 90% of thetotal treatment volume, but less than 100%, the dialysis machine 102,200, 300, 405, 455 may complete the treatment but also alert or alarm tonotify the user or medical professional. Although the patient mayreceive an effective level of treatment, the alarm may alert the user toa condition of the dialysis machine 102, 200, 300, 405, 455 to addressbefore beginning another treatment.

If at step 645 the dialysis machine 102, 200, 300, 405, 455 determinesthat the entire dialysate treatment has been delivered to the patient,the treatment may end at step 650.

Some embodiments of the disclosed system may be implemented, forexample, using a storage medium, a computer-readable medium or anarticle of manufacture which may store an instruction or a set ofinstructions that, if executed by a machine (i.e., processor ormicrocontroller), may cause the machine to perform a method and/oroperations in accordance with embodiments of the disclosure. Inaddition, a server or database server may include machine readable mediaconfigured to store machine executable program instructions. Such amachine may include, for example, any suitable processing platform,computing platform, computing device, processing device, computingsystem, processing system, computer, processor, or the like, and may beimplemented using any suitable combination of hardware, software,firmware, or combinations thereof and utilized in systems, subsystems,components, or sub-components thereof. The computer-readable medium orarticle may include, for example, any suitable type of memory unit,memory device, memory article, memory medium, storage device, storagearticle, storage medium and/or storage unit, for example, memory(including non-transitory memory), removable or non-removable media,erasable or non-erasable media, writeable or re-writeable media, digitalor analog media, hard disk, floppy disk, Compact Disk Read Only Memory(CD-ROM), Compact Disk Recordable (CD-R), Compact Disk Rewriteable(CD-RW), optical disk, magnetic media, magneto-optical media, removablememory cards or disks, various types of Digital Versatile Disk (DVD), atape, a cassette, or the like. The instructions may include any suitabletype of code, such as source code, compiled code, interpreted code,executable code, static code, dynamic code, encrypted code, and thelike, implemented using any suitable high-level, low-level,object-oriented, visual, compiled and/or interpreted programminglanguage.

As used herein, an element or operation recited in the singular andproceeded with the word “a” or “an” should be understood as notexcluding plural elements or operations, unless such exclusion isexplicitly recited. Furthermore, references to “one embodiment” of thepresent disclosure are not intended to be interpreted as excluding theexistence of additional embodiments that also incorporate the recitedfeatures.

The present disclosure is not to be limited in scope by the specificembodiments described herein. Indeed, other various embodiments of andmodifications to the present disclosure, in addition to those describedherein, will be apparent to those of ordinary skill in the art from theforegoing description and accompanying drawings. Thus, such otherembodiments and modifications are intended to fall within the scope ofthe present disclosure. Furthermore, although the present disclosure hasbeen described herein in the context of a particular implementation in aparticular environment for a particular purpose, those of ordinary skillin the art will recognize that its usefulness is not limited thereto andthat the present disclosure may be beneficially implemented in anynumber of environments for any number of purposes. Accordingly, theclaims set forth below should be construed in view of the full breadthand spirit of the present disclosure as described herein.

What is claimed is:
 1. A dialysis system for conducting a dialysistreatment, comprising: one or more dialysate containers arranged andconfigured to hold dialysate; a dialysis machine for transferring avolume of dialysate from the one or more dialysate containers to apatient; a dialysate reservoir container arranged and configured toreceive diverted dialysate; wherein, the dialysis machine is configuredto: flow the dialysate from the one or more dialysate containers to thepatient; detect for the volume of the dialysate, a temperature of thedialysate volume, an air content of the dialysate volume, or anothercondition, or combinations thereof, wherein the detected temperature ofthe dialysate volume is compared to a predetermined maximum temperature,the detected air content of the dialysate volume is compared to apredetermined maximum air content, or the detected other conditiongenerates a signal, or combinations thereof; and divert the volume ofdialysate to the dialysate reservoir container in response to thedetected temperature exceeding the predetermined maximum temperature,the air content exceeding the predetermined maximum air content, or theother condition generated signal, or combinations thereof; determine atotal amount of the volume of dialysate delivered to the patient;determine if the diverted volume of dialysate is acceptable for deliveryto the patient; in response to determining that the total amount of thevolume of dialysate delivered to the patient is below a dialysatetreatment volume and determining that the diverted volume of dialysateis acceptable for delivery, transferring the diverted volume ofdialysate from the dialysate reservoir container to the patient; and inresponse to determining that the total amount of the volume of dialysatedelivered to the patient is below a dialysate treatment volume anddetermining that the diverted volume of dialysate is unacceptable fordelivery, transmitting an alarm or an alert.
 2. The dialysis system ofclaim 1, further comprising a heater bag positioned on a top surface ofthe dialysis machine, the heater bag arranged and configured to changethe volume of the dialysate from a first temperature to a secondtemperature, the second temperature being greater than the firsttemperature, wherein the volume of dialysate is deliverable from the oneor more dialysate containers to the dialysis machine via the heater bagsuch that the dialysate is heatable by batch in the heater bag.
 3. Thedialysis system of claim 1, further comprising a warmer pouch insertableinto the dialysis machine, the warmer pouch arranged and configured toreceive the volume of dialysate from the one or more dialysatecontainers, the warmer pouch being arranged and configured to change thevolume of dialysate from a first temperature to a second temperature,the second temperature being greater than the first temperature, whereinthe volume of dialysate is delivered from the one or more dialysatecontainers to the dialysis machine via a warmer pouch.
 4. The dialysissystem of claim 3, wherein the warmer pouch is in-line with the dialysismachine, the warmer pouch being configured such that the dialysate iscontinuously flowable through the warmer pouch.
 5. The dialysis systemof claim 3, wherein the dialysis machine includes a slot, the warmerpouch being slideably insertable into the slot formed in the dialysismachine.
 6. The dialysis system of claim 1, wherein the diverted volumeof dialysate is deliverable to the patient after delivery of dialysatefrom all of the one or more dialysate containers.
 7. The dialysis systemof claim 1, wherein the diverted volume of dialysate is acceptable fordelivery to the patient in response to the detected temperature beingbelow the predetermined maximum temperature, the air content being belowthe predetermined maximum air content, or the other condition isacceptable, or combinations thereof.
 8. The dialysis system of claim 1,wherein the dialysate reservoir container is an additional holdingreservoir, an unused dialysate bag, or a used dialysate bag, orcombinations thereof.
 9. The dialysis system of claim 1, wherein thedialysis machine is configured to actively cool the volume of diverteddialysate.
 10. The dialysis system of claim 1, wherein the dialysismachine is configured to provide an active measurement of the diverteddialysate.
 11. The dialysis system of claim 1, wherein the othercondition includes detecting a new treatment set of a cartridge andtubing, priming the tubing, or detecting a treatment event alarm or flowstop, or combinations thereof.
 12. A dialysis system for conducting adialysis treatment, comprising: one or more dialysate containersarranged and configured to hold dialysate; a dialysis machine fortransferring a volume of dialysate from the one or more dialysatecontainers to a patient; a dialysate reservoir container arranged andconfigured to receive diverted dialysate; wherein, the dialysis machineis configured to: flow the dialysate from the one or more dialysatecontainers to the patient; detect for the volume of the dialysate, atemperature of the dialysate volume, an air content of the dialysatevolume, or another condition, or combinations thereof, wherein thedetected temperature of the dialysate volume is compared to apredetermined maximum temperature, the detected air content of thedialysate volume is compared to a predetermined maximum air content, orthe detected other condition generates a signal, or combinationsthereof; and divert the volume of dialysate to the dialysate reservoircontainer in response to the detected temperature exceeding thepredetermined maximum temperature, the air content exceeding thepredetermined maximum air content, or the other condition generatedsignal, or combinations thereof; determine a total amount of the volumeof dialysate delivered to the patient; determine if the diverted volumeof dialysate is acceptable for delivery to the patient; and in responseto determining that the total amount of the volume of dialysatedelivered to the patient is below a dialysate treatment volume anddetermining that the diverted volume of dialysate is acceptable fordelivery, transferring the diverted volume of dialysate from thedialysate reservoir container to the patient.
 13. The dialysis system ofclaim 12, wherein in response to determining that the total amount ofthe volume of dialysate delivered to the patient is below a dialysatetreatment volume and determining that the diverted volume of dialysateis unacceptable for delivery, transmitting an alarm or an alert.
 14. Thedialysis system of claim 12, wherein the diverted volume of dialysate isdeliverable to the patient after delivery of dialysate from all of theone or more dialysate containers.
 15. The dialysis system of claim 12,wherein the diverted volume of dialysate is acceptable for delivery tothe patient in response to the detected temperature being below thepredetermined maximum temperature, the air content being below thepredetermined maximum air content, or the other condition is acceptable,or combinations thereof.
 16. The dialysis system of claim 12, whereinthe dialysate reservoir container is an additional holding reservoir, anunused dialysate bag, or a used dialysate bag, or combinations thereof.17. The dialysis system of claim 12, wherein the dialysis machine isconfigured to actively cool the volume of diverted dialysate.
 18. Thedialysis system of claim 12, wherein the dialysis machine is configuredto provide an active measurement of the diverted dialysate.
 19. Thedialysis system of claim 12, wherein the other condition includesdetecting a new treatment set of a cartridge and tubing, priming thetubing, or detecting a treatment event alarm or flow stop, orcombinations thereof.
 20. The dialysis system of claim 12, furthercomprising a heater bag positioned on a top surface of the dialysismachine, the heater bag arranged and configured to change the volume ofthe dialysate from a first temperature to a second temperature, thesecond temperature being greater than the first temperature, wherein thevolume of dialysate is deliverable from the one or more dialysatecontainers to the dialysis machine via the heater bag such that thedialysate is heatable by batch in the heater bag.
 21. The dialysissystem of claim 12, further comprising a warmer pouch insertable intothe dialysis machine, the warmer pouch arranged and configured toreceive the volume of dialysate from the one or more dialysatecontainers, the warmer pouch being arranged and configured to change thevolume of dialysate from a first temperature to a second temperature,the second temperature being greater than the first temperature, whereinthe volume of dialysate is delivered from the one or more dialysatecontainers to the dialysis machine via a warmer pouch.
 22. The dialysissystem of claim 21, wherein the warmer pouch is in-line with thedialysis machine, the warmer pouch being configured such that thedialysate is continuously flowable through the warmer pouch.
 23. Thedialysis system of claim 21, wherein the dialysis machine includes aslot, the warmer pouch being slideably insertable into the slot formedin the dialysis machine.